Alvimopan Use in Polytraumatized Patients

Phase 4

Terminated

• Conditions: Post Operative Ileus
• Interventions: Drug: Alvimopan; Drug: Placebo

• Registration Number: NCT03068975
• Lead Sponsor: University of Puerto Rico

Brief Summary

To evaluate the efficacy and safety of Alvimopan(12 mg) in recovery of bowel function in an emergency trauma setting without the pre-operative dosage in patients that will receive abdominal surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-02-27
• Study First Posted: 2017-03-03
• Study Start: 2017-09-01
• Primary Completion: 2019-11-19
• Study Completion: 2019-11-19
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-31
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Ages 18 to 80
• Poly-traumatized patients
• Extubated patients after abdominal exploration
• Underwent Abdominal exploration, had colon resection with primary anastomosis with closure of abdomen

Exclusion Criteria

• Mechanically ventilated patients
• Patient not expected to survive Glasgow Coma Scale = 3
• Pregnant patients
• Apache score > 40 (observed mortality 100%) Saas Ahmed Naved et al 2011
• Vasopressor therapy
• Septic patients
• Thoracotomy
• Bogota bag
• Intravenous Drug Abuser (IVDA) as evidenced by urine toxicology upon admission to the Trauma Unit
• Patients with prior history of gastric surgery and/or colonic surgery
• Medical History: of severe cardiovascular disease, Renal diseases, Hepatitis C or Hepatic failure, Autoimmune disease, Crohn and Ulcerative Colitis (In view of the inflammation in the intestinal mucosal which may decrease optimal absorption of the medication) and or bowel obstruction
• Prior pancreatic anastomosis or gastric anastomosis; ostomy formation
• Chronic use of nonsteroidal anti-inflammatory drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alvimopan	Alvimopan	Patients in the study group will be administered a post operative dose of Alvimopan
Placebo	Placebo	Patients in the Placebo group will receive a placebo pill and will be compared with the study group

Primary Outcome Measures

Name	Time	Method
Recovery of bowel function in trauma patients who received post operative dose of Alvimopan compared to placebo.	2 years	Since Entereg is a peripherally opioid receptor antagonist it will bind to those receptors and will avoid the post operative ileus hence the bowel recovery will be faster. By physical examination (passage of flatus, bowel movements upon auscultation) will be used to assess recovery of bowel function

Secondary Outcome Measures

Name	Time	Method
Length of stay in patients of the same population who receive a placebo.	5 years	Since Entereg is a peripherally opioid receptor antagonist it will bind to those receptors and will avoid the post operative ileus and all the associated complications that prolonged the length of stay of the patients, hence it will reduce the hospital days of the individual

Trial Locations

Locations (1)

Puerto Rico Trauma Hospital; 🇵🇷 San Juan, Puerto Rico